Medical Device Development Services

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MEDICAL DEVICE HARDWARE AND SOFTWARE DEVELOPMENT

NOVO specializes in medical device development services for Class I, II, and III FDA-regulated devices. The scope of our ISO 13485:2016-certified quality management system (QMS) covers a five-phase product development process from concept through manufacturing transfer, including controlled builds for preclinical and clinical trial devices.

Our senior-level device engineering team works with our clients to establish a project plan that incorporates ISO-compliant documentation, regulatory submittals, clinical trials, V&V testing, and other regulated device development considerations, along with typical electro-mechanical device development activities. Our familiarity with a wide range of medical and non-medical devices, and our in-house development tools that include onsite rapid prototyping, CNC machining, and environmental testing are an asset to both our startup medical device clients and established product companies.

We have successfully used NOVO Engineering to accelerate our product development pathway in two development stage companies: DexCom, Inc. (NASAQ:DXCM), and Obalon Therapeutics, Inc. (NASDAQ: OBLN). At DexCom, NOVO's involvement helped us to create a successful design for a novel continuous glucose monitor ahead of schedule and leapfrog much larger competitors into the very large diabetes market.Andy Rasdal, President and CEO, Obalon Therapeutics